RE:FDA approved home self-test nasal swab w/30 min...Lucira Health has 'fleshed' out a few more details of interest regarding their new found focus....they pivoted from the research and knowledge gained it seems after 5 yrs working on a flu test kit and in 9 short months were able to get an FDA EUA for their self-administered,at-home,30 min nasal swab test kit,for the Covid-19 virus....which they plan to retail for $50 usd.
Seems only two clinics one in N.California and the other in Miami/Ft.Lauderdale will initially be able to get the kits(probably due to the fact if the user gets a positive reading they are expected to contact a health pro...in this case they seem to be directed to one of these two clinics associated with the co.) by Spring 2021 a national roll-out is expected...time it will take to ramp up manufacturing of the kits.
They also gave some sensitivity numbers:
Lucira test results were compared with one of the most reliable FDA authorized high sensitivity SARS- CoV-2 assays available. The comparative positive results agreed 94.1% of the time across all samples, and 100% of the time excluding samples containing very low levels of virus (at or below 37.5 Ct). The negative results agreed 98.0% of the time across all samples. Founded in 2013 near the UC- Berkeley...they have 40 employees.
The money/funding....a side interest maybe to some of us here....they have raised $52M from VC Funds plus some large NIH and Gates FDN funds/grants...no doubt an IPO might be on tap next yr or probably some bankers will at least try to make the pitch...VC funds do expect to get paid back...and then some.
If this start-up(literally started in one of the founders garage as per their bio) needed at least $52M give or take $20M(grants?)....to get their FDA EUA....How much is THRM projecting they will need to raise? glta
https://apnews.com/press-release/business-wire/business-pandemics-public-health-products-and-services-coronavirus-pandemic-20869ac5bba44b4e9b89e788684c28d2 https://apnews.com/press-release/business-wire/business-pandemics-public-health-products-and-services-coronavirus-pandemic-20869ac5bba44b4e9b89e788684c28d2
https://www.bizjournals.com/sanfrancisco/news/2020/11/18/covid-19-coronavirus-home-self-test-lucira-health.html
https://www.bizjournals.com/sanfrancisco/news/2020/11/18/covid-19-coronavirus-home-self-test-lucira-health.html https://app.dealroom.co/companies/diassess_inc_
https://app.dealroom.co/companies/diassess_inc_ https://www.lucirahealth.com/